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BPR - Biocidal Product Regulation. Control and Stability Testing

Sine Abraham Johannesen

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Biocidal Product Regulation

BPR - Biocidal Product Regulation. Control and Stability Testing

Biocide-containing products are subject to pan-European legislation. That means that all products containing active substances that are included on the Candidate List of the European Chemicals Agency (ECHA) have to be approved before they can be marketed. In order to obtain approval a number of data requirements specified in the Biocidal Products Regulation (BPR) have to be fulfilled.

The data requirements i.a. comprise physical-chemical testing and testing of the technical properties of the product. In some cases, testing follows the FAO manual with respect to the recipe type of the product. In other cases, tests are selected according to the specifications of the product.

Requirements are also made to the storage stability of the product. Tests of various parameters shall demonstrate a storage stability of at least 2 years. That applies to the content of the active substance and other physical-chemical properties of the product.

Requirements are made to the analysis method when quantifying the active substances in the recipe. The applied analysis methods shall live up to the requirements to linearity, specificity, recovery and precision that are described in the Biocidal Products Regulation with reference to SANCO 3030/99 rev. 4.

The Laboratory for Chemistry and Microbiology at Danish Technological Institute is accredited according to ISO 17025.

Efficiency tests according to EN standards are required for the recipes of the product type PT 1-5, see link: (https://www.dti.dk/specialists/efficacy-testing/product-approval-of-biocides-disinfectants-and-antiseptics/35729)

How can Danish Technological Institut help you?

 

 

 

 

 

 

 

According to Danish legislation, all biocidal products must undergo stability testing followed by several physical-chemical tests and measurements of active substances to test the durability of the product.

During the next 5 years, biocidal products will be subject to strict regulation.

Pursuant to the Biocidal Products Regulation (BPR), stability studies must be carried out on all biocidal products. The performance of an accelerated stability test and a stability test equal to the recommended storage time will be required.

Subsequently, it must be documented that the concentration of the active substance(s) remains unchanged, and that the physical-chemical properties remain unchanged.

Manufacturers/distributors or consumers often have products with biocides in stock for a longer time.

The stability of the product can depend on how the product has been stored. The temperature and packaging of a product can be decisive factors for the durability of a product.

Danish Technological Institute can carry out stability studies and subsequent physical-chemical tests of biocide-containing products, e.g., disinfectants, antiseptics and wood preservatives.

In addition, Danish Technological Institute can quantify many active substances, including: alcohols, chloride, aldehydes, quaternary ammonium compounds, phenols, oxidizing compounds and acids.

The Laboratory for Chemistry and Microbiology at Danish Technological Institute is accredited according to ISO 17025 and therefore meets the requirements in relation to ECHA.

How can Danish Technological Institute help you?

  • Set-up of test program
  • Accelerated stability studies according to CIPAC method 46.3
  • Accelerated stability studies at low temperature according to CIPAC method 39.3
  • Real time stability studies according to BPR part A, Vol I
  • Quantification of active substances
  • Screening of constituents
  • Physical-chemical tests of liquid products according to CIPAC methods
  • Physical-chemical tests of powder, granulates, tablets according to CIPAC methods.